SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1666-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.

Product Classification:

Class II

Date Initiated: May 7, 2013

Date Posted: July 10, 2013

Recall Number: Z-1666-2013

Event ID: 65442

Reason for Recall:

Potential for set screw to be come deformed.

Status: Terminated

Product Quantity: 61 individual inserter assemblies

Code Information:

Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R

Distribution Pattern:

Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama

Voluntary or Mandated:

Voluntary: Firm initiated